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Development and evaluation of multiple unit particulate system (MUPS) of topiramate for taste masking

Yıl 2024, Cilt: 28 Sayı: 4, 997 - 1009, 28.06.2025

Isaiah Boyapati Neerupma Dhiman Giriraj T Kulkarni

Öz

Multiple unit particulate system (MUPS) is a more recent, challenging, effective and attractive option for the pharmaceutical industries that gives an efficient way to deliver the drug in modified pattern. MUPS are the most preferred dosage forms considering their ease of administration and consistency in manufacturing. Topiramate, indicated for schizophrenia, has a very bitter taste. The aim of this study was to develop a MUPS dosage form for taste masking of topiramate. Inert sugar spheres were coated with topiramate by fluid bed technique using povidone as binder. The drug loaded pellets were taste masked with cellulose acetate as taste masking agent. In the taste masking coating also, povidone was used as a binder and pore former. Developed taste masked MUPS were evaluated for polymorphic changes, drug content and dissolution in various media. Drug content of all batches of MUPS were within the range of 95-105%. Dissolution profile of the taste masked topiramate MUPS in 0.1N HCl, acetate buffer (pH 4.5) and phosphate buffer (pH 6.8) was found to be satisfactory.

Anahtar Kelimeler

Taste masking MUPS Topiramate Fluid Bed processor

Kaynakça

  • [1] Shishu, Kamalpreet, Kapoor VR. Development of taste masked oral formulation of ornidazole. Indian J Pharm Sci. 2010; 72(2): 211-215. https://doi.org/10.4103/0250-474X.65018
  • [2] Gittings S, Turnbull N, Roberts CJ, Gershkovich P. Dissolution methodology for taste masked oral dosage forms. J Control Release. 2014; 173(10): 32-42. https://doi.org/10.1016/j.jconrel.2013.10.030
  • [3] Patel AR, Vavia PR. Preparation and evaluation of taste masked famotidine formulation using drug/β-cyclodextrin/polymer ternary complexation approach. AAPS PharmSciTech. 2008; 9: 544–550. https://doi.org/10.1208/s12249-008-9078-0
  • [4] El-Said IA, Aboelwafa AA, ElGazayerly ON. Optimization of taste-masked dapoxetine oral thin films using factorial design: in vitro and in vivo evaluation. Pharm Dev Technol. 2021; 26(5): 522-538. https://doi.org/10.1080/10837450.2021.1894445
  • [5] Auda SH, Al-Omrani AH, Alanazi FK, Badran MM, Shakeel F. Design, characterization and evaluation of oral fast dissolving polymeric films of isradipine inclusion complex. Polym. Bull. 2019; 76: 2453–2469. https://doi.org/10.1007/s00289-018-2503-y
  • [6] Fu Y, Jeong SH, Park K. Fast-melting tablets based on highly plastic granules. J Control Release. 2005; 109(1-3): 203-210. https://doi.org/10.1016/j.jconrel.2005.09.021
  • [7] Bruce LD, Petereit HU, Beckert T, McGinity JW. Properties of enteric coated sodium valproate pellets. Int J Pharm. 2003; 264(1-2): 85-96. https://doi.org/10.1016/s0378-5173(03)00392-2
  • [8] Fu Y, Yang S, Jeong SH, Kimura S, Park K. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst. 2004; 21(6): 433-475. https://doi.org/10.1615/critrevtherdrugcarriersyst.v21.i6.10
  • [9] Amelian A, Wasilewska K, Wesoły M, Ciosek-Skibińska P, Winnicka K. Taste-masking assessment of orally disintegrating tablets and lyophilisates with cetirizine dihydrochloride microparticles. Saudi Pharm J. 2017; 25(8): 1144–1150. https://doi.org/10.1016%2Fj.jsps.2017.06.001
  • [10] Strickley RG. Pediatric oral formulations: An updated review of commercially available pediatric oral formulations since 2007. J Pharm Sci. 2019; 108(4): 1335-1365. https://doi.org/10.1016/j.xphs.2018.11.013
  • [11] Smutzer G, Cherian S, Patel D, Lee BS, Lee K, Sotelo AR, Mitchell KW. A formulation for suppressing bitter taste in the human oral cavity. Physiol Behav. 2020; 226:113129. https://doi.org/10.1016/j.physbeh.2020.113129
  • [12] ICH Quality Guidelines Q3. https://www.ich.org/page/quality-guidelines (accessed on May 1, 2022).
  • [13] Samprasit W, Opanasopit P, Akkaramongkolporn P, Ngawhirunpat T, Wongsermsin K, Panomsuk S. Preparation and evaluation of taste-masked dextromethorphan oral disintegrating tablet. Pharm Dev Technol. 2012; 17(3): 315-320. https://doi.org/10.3109/10837450.2010.535828
  • [14] Hu S, Liu X, Zhang S, Quan D. An overview of taste-masking technologies: Approaches, application, and assessment methods. AAPS PharmSciTech. 2023; 24(2):67. https://doi.org/10.1208/s12249-023-02520-z
  • [15] Topiramate USP monograph. Interim Revision Announcement Official May 1, 2017. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/iras/topiramate.pdf (accessed on May 5, 2022).
  • [16] Ayenew Z, Puri V, Kumar L, Bansal AK. Trends in pharmaceutical taste masking technologies: a patent review. Recent Pat Drug Deliv Formul. 2009; 3(1): 26-39. https://doi.org/10.2174/187221109787158364
  • [17] Douroumis D. Practical approaches of taste masking technologies in oral solid forms. Expert Opin Drug Deliv. 2007; 4(4): 417-426. https://doi.org/10.1517/17425247.4.4.417
  • [18] Sohi H, Sultana Y, Khar RK. Taste masking technologies in oral pharmaceuticals: Recent developments and approaches. Drug Dev Ind Pharm. 2004; 30(5): 429-448. https://doi.org/10.1081/ddc-120037477
  • [19] Wesdyk R, Joshi YM, Jain NB, Morris K, Newman A. The effect of size and mass on the film thickness of beads coated in fluidized bed equipment. Int J Pharm 1990; 65(1-2): 69-76. https://doi.org/10.1016/0378-5173(90)90011-R
  • [20] Yan G, Liang Q, Wen X, Peng J, Deng R, Lv L, Ji M, Deng X, Wu L, Feng X, He J. Preparation, characterization, and pharmacokinetics of tilmicosin taste-masked formulation via hot-melt extrusion technology. Colloids Surf B Biointerfaces. 2020; 196:111293. https://doi.org/10.1016/j.colsurfb.2020.111293
  • [21] Dreu R, Luštrik M, Perpar M, Zun I, Srčič S. Fluid-bed coater modifications and study of their influence on the coating process of pellets. Drug Dev Ind Pharm. 2012; 38(4): 501-511. https://doi.org/10.3109/03639045.2011.617754
  • [22] Govender M, Choonara YE, van Vuuren S, Kumar P, du Toit LC, Pillay V. Design and evaluation of an oral multiparticulate system for dual delivery of amoxicillin and Lactobacillus acidophilus. Future Microbiol. 2016; 11(9): 1133-1145. https://doi.org/10.2217/fmb-2016-0059
  • [23] Mizumoto T, Tamura T, Kawai H, Kajiyama A, Itai S. Formulation design of an oral, fast-disintegrating dosage form containing taste-masked particles of famotidine. Chem Pharm Bull (Tokyo). 2008; 56(7): 946-950. https://doi.org/10.1248/cpb.56.946
  • [24] Topiramate Tablets Monograph. USP. Revision Bulletin Official October 1, 2010. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/tOPIRAMATETABLETS-M84314.pdf. (accessed on May 5, 2022).

Yıl 2024, Cilt: 28 Sayı: 4, 997 - 1009, 28.06.2025

Isaiah Boyapati Neerupma Dhiman Giriraj T Kulkarni

Öz

Kaynakça

  • [1] Shishu, Kamalpreet, Kapoor VR. Development of taste masked oral formulation of ornidazole. Indian J Pharm Sci. 2010; 72(2): 211-215. https://doi.org/10.4103/0250-474X.65018
  • [2] Gittings S, Turnbull N, Roberts CJ, Gershkovich P. Dissolution methodology for taste masked oral dosage forms. J Control Release. 2014; 173(10): 32-42. https://doi.org/10.1016/j.jconrel.2013.10.030
  • [3] Patel AR, Vavia PR. Preparation and evaluation of taste masked famotidine formulation using drug/β-cyclodextrin/polymer ternary complexation approach. AAPS PharmSciTech. 2008; 9: 544–550. https://doi.org/10.1208/s12249-008-9078-0
  • [4] El-Said IA, Aboelwafa AA, ElGazayerly ON. Optimization of taste-masked dapoxetine oral thin films using factorial design: in vitro and in vivo evaluation. Pharm Dev Technol. 2021; 26(5): 522-538. https://doi.org/10.1080/10837450.2021.1894445
  • [5] Auda SH, Al-Omrani AH, Alanazi FK, Badran MM, Shakeel F. Design, characterization and evaluation of oral fast dissolving polymeric films of isradipine inclusion complex. Polym. Bull. 2019; 76: 2453–2469. https://doi.org/10.1007/s00289-018-2503-y
  • [6] Fu Y, Jeong SH, Park K. Fast-melting tablets based on highly plastic granules. J Control Release. 2005; 109(1-3): 203-210. https://doi.org/10.1016/j.jconrel.2005.09.021
  • [7] Bruce LD, Petereit HU, Beckert T, McGinity JW. Properties of enteric coated sodium valproate pellets. Int J Pharm. 2003; 264(1-2): 85-96. https://doi.org/10.1016/s0378-5173(03)00392-2
  • [8] Fu Y, Yang S, Jeong SH, Kimura S, Park K. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst. 2004; 21(6): 433-475. https://doi.org/10.1615/critrevtherdrugcarriersyst.v21.i6.10
  • [9] Amelian A, Wasilewska K, Wesoły M, Ciosek-Skibińska P, Winnicka K. Taste-masking assessment of orally disintegrating tablets and lyophilisates with cetirizine dihydrochloride microparticles. Saudi Pharm J. 2017; 25(8): 1144–1150. https://doi.org/10.1016%2Fj.jsps.2017.06.001
  • [10] Strickley RG. Pediatric oral formulations: An updated review of commercially available pediatric oral formulations since 2007. J Pharm Sci. 2019; 108(4): 1335-1365. https://doi.org/10.1016/j.xphs.2018.11.013
  • [11] Smutzer G, Cherian S, Patel D, Lee BS, Lee K, Sotelo AR, Mitchell KW. A formulation for suppressing bitter taste in the human oral cavity. Physiol Behav. 2020; 226:113129. https://doi.org/10.1016/j.physbeh.2020.113129
  • [12] ICH Quality Guidelines Q3. https://www.ich.org/page/quality-guidelines (accessed on May 1, 2022).
  • [13] Samprasit W, Opanasopit P, Akkaramongkolporn P, Ngawhirunpat T, Wongsermsin K, Panomsuk S. Preparation and evaluation of taste-masked dextromethorphan oral disintegrating tablet. Pharm Dev Technol. 2012; 17(3): 315-320. https://doi.org/10.3109/10837450.2010.535828
  • [14] Hu S, Liu X, Zhang S, Quan D. An overview of taste-masking technologies: Approaches, application, and assessment methods. AAPS PharmSciTech. 2023; 24(2):67. https://doi.org/10.1208/s12249-023-02520-z
  • [15] Topiramate USP monograph. Interim Revision Announcement Official May 1, 2017. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/iras/topiramate.pdf (accessed on May 5, 2022).
  • [16] Ayenew Z, Puri V, Kumar L, Bansal AK. Trends in pharmaceutical taste masking technologies: a patent review. Recent Pat Drug Deliv Formul. 2009; 3(1): 26-39. https://doi.org/10.2174/187221109787158364
  • [17] Douroumis D. Practical approaches of taste masking technologies in oral solid forms. Expert Opin Drug Deliv. 2007; 4(4): 417-426. https://doi.org/10.1517/17425247.4.4.417
  • [18] Sohi H, Sultana Y, Khar RK. Taste masking technologies in oral pharmaceuticals: Recent developments and approaches. Drug Dev Ind Pharm. 2004; 30(5): 429-448. https://doi.org/10.1081/ddc-120037477
  • [19] Wesdyk R, Joshi YM, Jain NB, Morris K, Newman A. The effect of size and mass on the film thickness of beads coated in fluidized bed equipment. Int J Pharm 1990; 65(1-2): 69-76. https://doi.org/10.1016/0378-5173(90)90011-R
  • [20] Yan G, Liang Q, Wen X, Peng J, Deng R, Lv L, Ji M, Deng X, Wu L, Feng X, He J. Preparation, characterization, and pharmacokinetics of tilmicosin taste-masked formulation via hot-melt extrusion technology. Colloids Surf B Biointerfaces. 2020; 196:111293. https://doi.org/10.1016/j.colsurfb.2020.111293
  • [21] Dreu R, Luštrik M, Perpar M, Zun I, Srčič S. Fluid-bed coater modifications and study of their influence on the coating process of pellets. Drug Dev Ind Pharm. 2012; 38(4): 501-511. https://doi.org/10.3109/03639045.2011.617754
  • [22] Govender M, Choonara YE, van Vuuren S, Kumar P, du Toit LC, Pillay V. Design and evaluation of an oral multiparticulate system for dual delivery of amoxicillin and Lactobacillus acidophilus. Future Microbiol. 2016; 11(9): 1133-1145. https://doi.org/10.2217/fmb-2016-0059
  • [23] Mizumoto T, Tamura T, Kawai H, Kajiyama A, Itai S. Formulation design of an oral, fast-disintegrating dosage form containing taste-masked particles of famotidine. Chem Pharm Bull (Tokyo). 2008; 56(7): 946-950. https://doi.org/10.1248/cpb.56.946
  • [24] Topiramate Tablets Monograph. USP. Revision Bulletin Official October 1, 2010. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/tOPIRAMATETABLETS-M84314.pdf. (accessed on May 5, 2022).
Toplam 24 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular İlaç Dağıtım Teknolojileri
Bölüm Articles
Yazarlar

Isaiah Boyapati 0000-0001-9580-6389

Neerupma Dhiman 0000-0001-8168-1511

Giriraj T Kulkarni 0000-0002-9563-9469

Yayımlanma Tarihi 28 Haziran 2025
Yayımlandığı Sayı Yıl 2024 Cilt: 28 Sayı: 4

Kaynak Göster

APA Boyapati, I., Dhiman, N., & Kulkarni, G. T. (2025). Development and evaluation of multiple unit particulate system (MUPS) of topiramate for taste masking. Journal of Research in Pharmacy, 28(4), 997-1009.
AMA Boyapati I, Dhiman N, Kulkarni GT. Development and evaluation of multiple unit particulate system (MUPS) of topiramate for taste masking. J. Res. Pharm. Temmuz 2025;28(4):997-1009.
Chicago Boyapati, Isaiah, Neerupma Dhiman, ve Giriraj T Kulkarni. “Development and Evaluation of Multiple Unit Particulate System (MUPS) of Topiramate for Taste Masking”. Journal of Research in Pharmacy 28, sy. 4 (Temmuz 2025): 997-1009.
EndNote Boyapati I, Dhiman N, Kulkarni GT (01 Temmuz 2025) Development and evaluation of multiple unit particulate system (MUPS) of topiramate for taste masking. Journal of Research in Pharmacy 28 4 997–1009.
IEEE I. Boyapati, N. Dhiman, ve G. T. Kulkarni, “Development and evaluation of multiple unit particulate system (MUPS) of topiramate for taste masking”, J. Res. Pharm., c. 28, sy. 4, ss. 997–1009, 2025.
ISNAD Boyapati, Isaiah vd. “Development and Evaluation of Multiple Unit Particulate System (MUPS) of Topiramate for Taste Masking”. Journal of Research in Pharmacy 28/4 (Temmuz 2025), 997-1009.
JAMA Boyapati I, Dhiman N, Kulkarni GT. Development and evaluation of multiple unit particulate system (MUPS) of topiramate for taste masking. J. Res. Pharm. 2025;28:997–1009.
MLA Boyapati, Isaiah vd. “Development and Evaluation of Multiple Unit Particulate System (MUPS) of Topiramate for Taste Masking”. Journal of Research in Pharmacy, c. 28, sy. 4, 2025, ss. 997-1009.
Vancouver Boyapati I, Dhiman N, Kulkarni GT. Development and evaluation of multiple unit particulate system (MUPS) of topiramate for taste masking. J. Res. Pharm. 2025;28(4):997-1009.